STEPS Study
Research type
Research Study
Full title
Study of TRE Seals on Early Post-operative Subjects (STEPS)
IRAS ID
242748
Contact name
Susan Pridham
Contact email
Sponsor organisation
Hollister Incorporated
Duration of Study in the UK
0 years, 8 months, 30 days
Research summary
Objective(s):
The objective of this study is to assess the clinical and economic impact of the Dansac TRE Seal and Coloplast Brava Protective seal when used by newly post-operative stoma patients.Study Design:
The study will take place at one or more sites and is an open-label parallel randomized controlled trial which will utilize an adaptive design featuring sample size re-estimation.Study Period:
Subjects will be enrolled at Visit 1 (at the first pouching system change after surgery, approximately Day 1 post-op). Subjects will participate in study visits at 1 week, 3 weeks, 6 weeks, and 9 weeks post-op for a total of 5 visits over the course of 9 weeks.Target Number of Subjects:
A convenience sample size of 60 subjects will be targeted.Eligibility Criteria:
Subjects to be enrolled in this study are newly post-operative stoma creation surgery patients with any type of ostomy and deemed appropriate by the Investigator for the use of a seal.Study Product:
The test product (Dansac TRE Seal, (Dansac, Fredensborg, Denmark) is a CE marked ostomy seal designed to maintain adhesive and absorption properties as well as maintain the skin’s natural pH balance. It is currently marketed in the UK and Japan.The control product (Coloplast Brava Protective Seal, (Coloplast, Humlebæk, Denmark) is a CE marked ostomy seal designed to protect against leakage and protect the skin by absorbing moisture and leaving minimal residue behind. It is currently marketed in the UK and other countries.
Statistical Methods:
Data collected for the primary and secondary objective will be analyzed using appropriate statistical methods as defined by the variable’s data-level (e.g. continuous, ordinal, categorical, etc.). The analyses will be descriptive and characteristic in nature and any statistical tests will be exploratory with the exception of the sample size re-estimation which will be based on statistically controlled comparisons.Sample Size and Power:
A convenience sample size of 60 subjects was chosen for this study. No formal power calculations were performed to determine sample size. At the interim analysis, a sample size re-estimation will be performed to assess and adjust the sample size as appropriate.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0106
Date of REC Opinion
8 Mar 2018
REC opinion
Unfavourable Opinion